Approved, investigational, or neither: a status table for 27 peptides
One table, three statuses. Which peptides have an FDA-approved product, which are in a sponsor's trial program, and which have neither, with the compounding category and WADA line for each, as of September 21, 2026.
Of the 27 peptides and peptide-adjacent compounds on this page, eight are the active ingredient of an FDA-approved product, two are in a sponsor's Phase 3 program with no approval, and the remaining seventeen have neither a US approval nor a sponsor-run US program. "Approved" applies to a specific product from a specific company, never to a research vial of the same molecule. Every row below is checked against Drugs@FDA, FDA's compounding category lists, ClinicalTrials.gov or the WADA 2026 Prohibited List, as of September 21, 2026.
What the three statuses mean
Approved means Drugs@FDA lists a product whose active ingredient is that molecule, with an application number and an approval date. The approval belongs to the product and its sponsor. A vial of the same sequence bought from a research supplier is not that product, was not made under that application, and is not covered by it.
Investigational means a company is running registered trials under an investigational new drug application and has not received an approval. The trial drug is the sponsor's material, made and released under the sponsor's controls. Research vials sold under the same name are not the trial drug.
Neither means no product in Drugs@FDA and no sponsor-run US program. Most of the molecules people search for sit here. Many of them were nominated for FDA's 503A bulks list, which is a separate question from approval and is explained in 503A, 503B and research use only.
Two columns need a note. The 503A/503B column reports FDA's interim-policy categories: Category 1 is where FDA has said it does not intend to act against compounders who meet the guidance conditions; Category 2 is where FDA has identified significant safety concerns; "withdrawn" means the nominator pulled the nomination and the substance is now in no category at all. The WADA column reports where the 2026 Prohibited List names a substance. "Not named" is not a clearance: the List's S0 class and its "similar chemical structure or similar biological effect(s)" clauses are catch-alls, which is covered in WADA S0, S2 and strict liability.
Which peptides have an FDA-approved product?
| Peptide | Class | Approved product (Drugs@FDA) | 503A/503B note | WADA 2026 |
|---|---|---|---|---|
| Semaglutide | GLP-1 receptor agonist | Ozempic, NDA 209637, Novo Nordisk, December 5, 2017; Rybelsus, NDA 213051, September 20, 2019; Wegovy, NDA 215256, June 4, 2021 | Compounding enforcement discretion during the shortage ended April 22, 2025 (503A) and May 22, 2025 (503B); see what ended for compounded semaglutide and tirzepatide | Not named |
| Tirzepatide | GIP and GLP-1 receptor agonist | Mounjaro, NDA 215866, Eli Lilly, May 13, 2022; Zepbound, NDA 217806, November 8, 2023 | Discretion ended February 18, 2025 (503A) and March 19, 2025 (503B) | Not named |
| Liraglutide | GLP-1 receptor agonist | Victoza, NDA 022341, Novo Nordisk, January 25, 2010; Saxenda, NDA 206321, December 23, 2014; generic ANDAs from December 2024 | FDA proposed on April 30, 2026 to exclude it, with semaglutide and tirzepatide, from the 503B bulks list; outcome not published | Not assessed here |
| Sermorelin | GHRH(1-29) analogue | Geref, NDA 020443, EMD Serono, September 26, 1997; marketing status Discontinued, which Drugs@FDA notes was not for safety or effectiveness reasons | On FDA's 503B Category 1 list marked as a component of an approved drug; see sermorelin, tesamorelin, ipamorelin and CJC-1295 | S2.2.4, named |
| Tesamorelin | GHRH analogue | Egrifta, BLA 022505, Theratechnologies, November 10, 2010; Prescription | Research "Tesamorelin" was cited as an unapproved new drug in FDA's August 2026 letters | S2.2.4, named |
| Bremelanotide (PT-141) | Melanocortin receptor agonist | Vyleesi, NDA 210557, Cosette, June 21, 2019; Prescription | Research "PT-141" was cited as an unapproved new drug in the 2026 letters and appears on Import Alert 66-41's Red List; see Melanotan II and PT-141 | Not named |
| Afamelanotide (Melanotan I) | Melanocortin receptor agonist | Scenesse, NDA 210797, Clivunel, October 8, 2019; Prescription | No category entry found | Not assessed here |
| Elamipretide (SS-31) | Tetrapeptide amide (D-Arg-Dmt-Lys-Phe-NH2) | Forzinity, NDA 215244, Stealth BioTherapeutics, September 19, 2025; Prescription | Research "SS-31" was cited as an unapproved new drug in the August 2026 letters | Not assessed here |
Which peptides are investigational with no approval?
| Peptide | Class | Sponsor and stage | 503A/503B note | WADA 2026 |
|---|---|---|---|---|
| Retatrutide | GIP, GLP-1 and glucagon receptor agonist | Eli Lilly (LY3437943), Phase 3; for example NCT06383390 and NCT06859268 active, not recruiting | Not on any 503A category list; named as an unapproved new drug in FDA's 2026 warning letters | Not named |
| Cagrilintide | Amylin analogue | Novo Nordisk, Phase 3, co-formulated with semaglutide in the CagriSema program (NCT06131437 completed; NCT07564414 recruiting) | Not on any category list; named in the March 31, 2026 CBP Cincinnati release; see cagrilintide is an amylin analogue | Not named |
A research vial labelled retatrutide is a catalog item with a sequence, a certificate and a lot number. It is not LY3437943 as made and released by its sponsor, and nothing on this site represents it as such. What investigational status means in practice is set out in retatrutide is investigational.
Which peptides have neither?
| Peptide | Class | US approval | 503A/503B note (as of September 21, 2026) | WADA 2026 |
|---|---|---|---|---|
| BPC-157 | Pentadecapeptide | None. Only US-sited record is a University of Arkansas Phase 1, not yet recruiting (NCT07803250) | 503A Category 2 from September 29, 2023; nominations withdrawn, reflected April 22, 2026; not in Category 1; FDA staff proposed in July 2026 that it not be listed | S0, named |
| TB-500 (thymosin beta-4 fragment LKKTETQ) | Protein fragment | None; only trial is a Hudson Biotech Phase 1/2 in China (NCT07487363) | Withdrawn April 22, 2026; FDA proposed not to list; see TB-500 and thymosin beta-4 are not the same molecule | S2.3, "Thymosin-ß4 and its derivatives e.g. TB-500" |
| Thymosin alpha-1 (thymalfasin) | N-acetylated peptide, MW 3108.3 | None; no thymalfasin entry in Drugs@FDA; US-sited trials are registered (SciClone Phase 3 studies in hepatitis C, completed) with no approved product | Outside 503A Category 2 by September 27, 2024; listed as withdrawn April 22, 2026 | Not assessed here |
| KPV | Tripeptide, alpha-MSH(11-13) | None; no ClinicalTrials.gov record | Withdrawn April 22, 2026; FDA proposed not to list; FDA: "FDA has not identified any human exposure data on drug products containing KPV" | Not named |
| MOTS-c | 16-residue mitochondrial-derived peptide | None; only trial is Hudson Biotech Phase 2, China (NCT07505745) | Withdrawn April 22, 2026; FDA proposed not to list | S4.4.1, named as an AMPK activator |
| Semax | Heptapeptide, ACTH(4-7) analogue | None; no ClinicalTrials.gov record | Withdrawn April 22, 2026; FDA proposed not to list | Not named |
| Selank | Heptapeptide, tuftsin analogue | None; no ClinicalTrials.gov drug record | Outside 503A Category 2 by September 27, 2024; listed as withdrawn April 22, 2026, as "Selank acetate (TP-7)" | Not named |
| Epitalon | Tetrapeptide AEDG | None; no ClinicalTrials.gov record | Withdrawn April 22, 2026; FDA proposed not to list | Not named |
| DSIP (emideltide) | Nonapeptide | None | Withdrawn April 22, 2026; FDA proposed not to list; the only one of the seven July 2026 PCAC substances reported by press as voted down | Not named |
| Kisspeptin-10 | Decapeptide | None; US Phase 1 records at Massachusetts General Hospital are withdrawn | Still in 503A Category 2, added September 29, 2023 | S2.2.1, "kisspeptin and its agonist analogues" |
| CJC-1295 | GHRH analogue with a drug affinity complex | None; ConjuChem Phase 2 NCT00267527 terminated | Outside 503A Category 2 by September 27, 2024; listed as withdrawn April 22, 2026 | S2.2.4, named |
| Ipamorelin | Pentapeptide amide (Aib-His-D-2-Nal-D-Phe-Lys-NH2), ghrelin receptor agonist | None; Helsinn Phase 2 trials completed (NCT01280344, NCT00672074) | 503B Category 2 since September 29, 2023, still listed; 503A nomination withdrawn | S2.2.4, named among GHS |
| Melanotan II | Cyclic melanocortin agonist | None; only trial is Hudson Biotech Phase 2, China (NCT07437560) | 503A Category 2 from September 29, 2023, withdrawn April 22, 2026; on Import Alert 66-41's Red List (CanLab entry) | Not named |
| AOD-9604 | Growth hormone C-terminal fragment | None; no ClinicalTrials.gov record | Outside 503A Category 2 by September 27, 2024; listed as withdrawn April 22, 2026 | S2.2.3, "growth hormone fragments, e.g. AOD-9604" |
| GHK-Cu | Copper tripeptide | None as a drug; the only registered drug trial is a Hudson Biotech Phase 2 topical study in China (NCT07437586) | 503A Category 1 for all but one route of administration, in FDA's wording, re-added after May 5, 2026; the withdrawn route left Category 2 April 22, 2026; FDA intends to consult PCAC before the end of February 2027 | Not named |
| NAD+ (not a peptide) | Dinucleotide | No approved product; FDA's 503B Category 1 list carries it without the approved-component mark | 503A Category 1 as "Nicotinamide Adenine Dinucleotide (NAD)" | Not named |
| 5-amino-1MQ (not a peptide) | Quinolinium small molecule | None; no ClinicalTrials.gov record | Not on any 503A or 503B category list | Not assessed here |
The last two rows are included because NAD+ and 5-amino-1MQ sit on peptide shelves, including ours, and are asked about in the same breath. Neither is a chain of amino acids; which of these "peptides" are peptides explains both, and glutathione beside them.
What "withdrawn" means, and what it does not
Nine of the rows above changed on April 22, 2026, when FDA's Category 2 page moved twelve peptides to a section headed "nominated but withdrawn": a procedural event, not a safety finding, that leaves each substance in no category and off the 503A bulks list. The full sequence, including the July 2026 advisory committee meeting at which FDA staff proposed that seven of them not be listed, is in Category 1, Category 2 and the 503A bulks list, and the most-searched case is in BPC-157 in 2026.
Why an approved product and a research vial are not the same thing
Approval attaches to an application: a named sponsor, a manufacturing process, a specification, a label. Geref's approval from 1997 belongs to EMD Serono's product, and that product is discontinued. It says nothing about a vial of sermorelin sold as a research reagent, which is what we stock. The same is true of Vyleesi and a research vial of bremelanotide, and of Forzinity and a vial labelled SS-31.
This cuts the other way too. FDA's August 2026 warning letters cite sellers of research "Tesamorelin," "PT-141" and "SS-31" for marketing unapproved new drugs, even though an approved product with the same active ingredient exists. What made the research product a drug in FDA's reading was the seller's own text, which is the subject of what FDA reads before calling a research product a drug.
Reading the table
Use the first column to find the molecule, then read across. If the "approved product" cell names a product, that product is the only form of the molecule with an FDA approval. If the 503A/503B cell says "withdrawn" or "Category 2," no pharmacy pathway under section 503A exists for it today. If the WADA cell names a section, the substance is prohibited in sport at all times regardless of its FDA status. The full catalog, with each item's identity data, is at the catalog.
Sources
- Drugs@FDA: Ozempic, NDA 209637, FDA
- Drugs@FDA: Mounjaro, NDA 215866, FDA
- Drugs@FDA: Victoza, NDA 022341, FDA
- Drugs@FDA: Geref, NDA 020443, FDA
- Drugs@FDA: Egrifta, BLA 022505, FDA
- Drugs@FDA: Vyleesi, NDA 210557, FDA
- Drugs@FDA: Scenesse, NDA 210797, FDA
- Drugs@FDA: Forzinity, NDA 215244, FDA
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, FDA, content current April 22, 2026
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (PDF), FDA, updated May 14, 2026
- FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, FDA, content current April 1, 2026
- 503B bulk drug substance categories (PDF), FDA, updated March 21, 2025
- ClinicalTrials.gov API v2 query for GHK-Cu, National Library of Medicine, queried September 21, 2026
- The 2026 Prohibited List (PDF), World Anti-Doping Agency, valid January 1, 2026
For laboratory research use only. Not a drug, not a supplement, and nothing here is a claim about what any of this material does in a person or an animal.

